Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base

NCT07145931 | Not Yet Recruiting Phase 2

• 1 other identifier: GHKQ-202503-L011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:

• What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma?
• Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition?
• Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety. Participants will:
• Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg/m² on Day 1, cisplatin 75mg/m² on Days 1-3) for 3 cycles.
• Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy.
• Receive (chemo)radiotherapy 4-6 weeks after surgery.
• Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.

Conditions

Head and Neck Cancer Squamous Cell Carcinoma; Skull Base--Cancer; Neoadjuvant Chemoimmunotherapy; Objective Response Rate

Keywords

Head and Neck Cancer Squamous Cell Carcinoma; Skull Base--Cancer; Neoadjuvant Chemoimmunotherapy; Objective response rate

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective Response Rate (ORR) is a pivotal efficacy endpoint in oncology therapeutic evaluation, defined as the proportion of patients whose tumor burden shrinks to a prespecified threshold (achieving either complete or partial response). This metric is measured using internationally standardized criteria (RECIST 1.1), with radiographic imaging to monitor changes in the sum of target lesion diameters. Based on Standardized Criteria (e.g., RECIST 1.1). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in tumor size (sum of target lesions). ORR = CR + PR (expressed as a percentage).

  Within 3 weeks after completion of neoadjuvant therapy

Secondary Outcomes (8)

• Number of participants with Adverse Events

  Until 21 days after the end of the study

• Pathologic Efficacy

  Perioperative

• Clinical Downstaging Rate

  Within 3 weeks after completion of neoadjuvant therapy.

• Surgical Conversion Rate

  Within 3 weeks after completion of neoadjuvant therapy.

• R0 Resection Rate

  Perioperative

Study Arms (1)

Treatment group

EXPERIMENTAL

* Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles. * Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy. * Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery. * Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.

Procedure: Neoadjuvant chemoimmunotherapy; Drug: Tislelizumab Nab paclitaxel

Interventions

Neoadjuvant chemoimmunotherapy PROCEDURE

* Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles. * Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy. * Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery. * Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.

Also known as: Surgery, Adjuvant immunotherapy

Treatment group

Tislelizumab Nab paclitaxel DRUG

Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.

Also known as: Cisplatin

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years, regardless of gender;
• Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla/mandible) with radiological evidence of skull base invasion;
• Measurable tumor lesions (meeting RECIST v1.1 criteria);
• Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);
• ECOG PS score: 0-1;
• Medically fit for surgery and chemotherapy, with no surgical contraindications;
• Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;
• Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.

You may not qualify if:

• Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;
• Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;
• Patients with known allergies to any study medications;
• Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin \<60g/L, WBC \<3.0×10⁹/L, platelets \<80×10⁹/L, or serum creatinine \>133μmol/L - such patients may be recommended for conservative treatment;
• Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;
• Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);
• Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);
• Participation in other clinical trials within 30 days prior to enrollment;
• Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial/social factors.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, 510055, China

Location

Related Publications (15)

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MeSH Terms

Interventions

Surgical Procedures, Operative; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yujie Liang

  Hospital of Stomatology, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Liang

CONTACT

+86 13242879610; liangyj35@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DDS, PhD, Associate Professor, Chief Physician

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 28, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: The researchers obtained study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code via email communication.

Locations

CN (1)